Senior Manager, Vendor Management
Description Reporting to the Associate Director, GXP Vendor Management & Self-Inspection Program, the Senior Manager, Vendor Management will be responsible for ensuring compliance with Health Authorities requirements on Quality and Compliance GXP internal and external auditing programs. This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management. Responsibilities (including, but not limited to):
- Represent Viridian with internal and external customers for GXP auditing activities
- Support risk-based analyses to establish frequency and depth of internal and external audits
- Schedule internal and external audits as needed
- Conduct internal and external audits ensuring customers and functional areas are following applicable regulations.
- Author, review and track internal and external audit reports
- Manage timely execution of audit scheduling, execution, and responses
- Maintain GxP audit files
- Support vendor management activities (e.g., Quality Agreements, Periodic Review, Approved Vendor List Maintenance)
- Generate, maintain, and report Quality metrics assessing compliance of internal functions and external vendors
- Maintain and improve Quality Audit program procedures
- Escalate any critical Quality issues to Sr Management in a timely manner
- Participate in pre-approval inspection readiness initiatives
- Support as the SME during inspections and support the inspection management team
- Support site QA organizations during regulatory inspections
Requirements
- Requires a BS degree in life sciences, engineering, or related field with 8+ years of experience working in a quality role in GxP pharmaceuticals
- Experience conducting internal and external audits (auditor qualification preferred)
- Experience supporting GxP regulatory inspections
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast-paced environment and to handle multiple tasks
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 40%
- The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
- Competitive pay and stock options for all employees
- Medical, dental, and vision insurance
- 100% Paid Parental Leave
- Short- and long-term disability coverage
- Life, Travel and AD&D
- 401(k) Company Match with immediate company vest
- Employee Stock Purchase plan
- Generous vacation plan and paid company holiday shutdowns
- Various fertility, mental, financial, and proactive physical health programs